HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders

NCT06973512 | Recruiting DMC FDA Device

• 1 other identifier: CTO Project ID: 4520
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Substance use disorder (SUD) or addiction to drugs/alcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances. Over 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects. SEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person. In the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care. SUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.

Conditions

Substance Use Disorder (SUD); Addiction

Keywords

addiction; substance use disorder; deep brain stimulation; stereoelectroencephalography; biomarker; electrophysiology

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-Related Adverse Events

  Adverse events associated with SEEG and DBS will be recorded.

  From enrolment to study conclusion at 12 months.

• Feasibility Assessed by Recruitment Rates and Protocol Adherence

  Feasibility will be evaluated through the following metrics: 1. Recruitment Rates: yearly and total number of participants recruited. 2. Protocol Adherence: percentage of completed study visits.

  Across 3 years of the anticipated study length.

Secondary Outcomes (6)

• Proportion of Negative Urine Toxicology for Primary Substance (%) Assed by Urinalysis

  From enrolment to study conclusion at 12 months.

• Change From Baseline in Days of Primary Substance Use Assessed by Timeline Follow-Back Self-Report

  From enrolment to study conclusion at 12 months.

• Self-Reported Substance Craving Assessed Using a 0-10 Visual Analog Scale

  From enrolment to study conclusion at 12 months.

• Depressive Symptom Severity Assessed by Patient Health Questionnaire (PHQ-9)

  From enrolment to study conclusion at 12 months.

• Anxiety Symptom Severity Asssed by General Anxiety Disorder (GAD-7)

  From enrolment to study conclusion at 12 months.

Study Arms (1)

Treatment

EXPERIMENTAL

There will be one arm where everyone will receive DBS

Device: deep brain stimulation and stereoelectroencephalography

Interventions

deep brain stimulation and stereoelectroencephalography DEVICE

Deep brain stimulation guided by stereoelectroencephalography

Also known as: deep brain stimulation, stereoelectroencephalography

Treatment

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, Age 25-65
• Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5)
• Treatment refractory as evidenced by non-response to an adequate trial of ≥2 evidence-based treatment modalities for their substance use disorder in the most recent 3 years of illness, as determined by the study clinical team
• Able to comply with study visit schedule and timeline
• Stable housing and reliable transportation
• Treatment-seeking (\>7 on a 0-10 readiness ruler and open to the end-of-treatment outcome of abstinence)
• Capable of understanding and providing informed consent

You may not qualify if:

• Contraindications to neurosurgical interventions such as major medical co-morbidities, including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant-related infections, immunocompromised state, or malignancy with \<5 years life expectancy
• Contraindications for MRI, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces
• Cardiac pacemaker/defibrillator, or other implanted stimulator
• Presence of epilepsy, stroke, or degenerative disorder of the nervous system
• Serious problems with literacy, vision, or hearing

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health / Toronto Western Hospital

Toronto, Ontario, 399 Bathurst St, Canada

RECRUITING

MeSH Terms

Conditions

Behavior, Addictive; Substance-Related Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Victor Addiction psychiatrist and scientist, MD, MSc

CONTACT

416-535-8501; Victor.Tang@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Addiction Psychiatrist and Clinician Scientist

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: May 15, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CA (1)